Apply now Sr Mgr Regulatory Affairs Date Jul 25 2025 Location Bangalore India 566064 Company Teva Pharmaceuticals Job Id 62866 Who we are Together we re on a mission to make good health more affordable and accessible to help millions around the world enjoy healthier lives It s a mission that bonds our people across nearly 60 countries and a rich diverse variety of nationalities and backgrounds Working here means working with the world s leading manufacturer of generic medicines and the proud producer of many of the products on the World Health Organization s Essential Medicines List Today at least 200 million people around the world take one of our medicines every single day An amazing number but we re always looking for current ways to continue making a difference and new people to make a difference with The opportunity Ensure pharmaceutical medical and regulatory accuracy of English product information SmPC Labeling PIL for European procedures MRP DCP CP of innovative biosimilar and generic products Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving Ensure regulatory compliance for all maintained innovative biosimilar and generic EU procedures MRP DCP CP regarding labeling Support team members with complex issues as a senior expert especially in responsibilities 2-6 Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership How you ll spend your day Department Leadership Organize and coordinate departmental tasks personnel management and planning Manage budget and resource planning Establish productive internal and cross-departmental processes Lead projects related to labeling including project management Review and approve SOPs for the department and overall processes Support division leadership and develop strategy principles and guidelines Team Leadership Organize and coordinate team tasks personnel management and planning Plan team activities and align with other teams Labeling Responsible for creating and updating compliant English product information for EU procedures Strategic planning and implementation of changes affecting multiple product information documents Determination of an implementation plan and tracking the implementation of updates due to new requirements e g new excipients warnings QRD template update Providing instructions and guidance to local RA e g calculations due to new excipients warnings Discussion of the content of product information for innovative products pre- and post-approval in project teams Evaluate and approve change requests coordinate submissions with EU regulatory units Collaborate on patent-related issues with Global IP Group Contribute to readability studies and ensure PIL readability and compliance with legal requirements Adaption to reference medicinal product generic hybrid biosimilar procedures Preparation of Expert statements justification for type II variations Providing scope of variation to regulatory affairs Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates Monitoring Monthly monitoring and communicating safety updates from EU authority websites Track reference product updates and legal guidance changes affecting product information Pharmacovigilance Assess need for updates based on Company Core Safety Information CCSI Implement PV-triggered and non-PV-triggered safety updates e g PRAC PSUSA PSUFU Referrals Articles 31 107i article 30 procedures etc in line with SOPs collaborate on safety-related actions with Pharmacovigilance and QA Participation in Product Safety Group PSG Meetings Implementation of internal signals including determining PIL wording Scientific Work Authority Communication Participate in project teams to fix the regulatory strategy and prepare expert statements Respond to authority deficiency letters in collaboration with other departments Mock-ups Coordinate creation and approval of packaging mock-ups Braille and specimens Address authority queries and ensure compliance with EU regulations Industry Representation Participate in working groups e g Medicines for Europe to represent the company as an EU labeling expert Your experience and qualifications Experience 12 years of total experience and minimum 8 years in relevant fields medicinal information and EU labeling in the pharmaceutical industry ideally in Regulatory Affairs with at least 3 years of leadership experience Education Completed at least 8-semester university degree in natural sciences e g Pharmacy preferred Biology Human Biology Medicine Food Chemistry preferably with a Ph D Additional leadership qualification is preferred Other Advanced English spoken and written strong MS Office skills excellent knowledge of EU pharmaceutical law regulatory affairs and related legal areas Project management experience required Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment It is Teva s global policy that equal employment opportunity be provided without regard to age race creed color religion sex disability pregnancy medical condition sexual orientation gender identity or expression ancestry veteran status national or ethnic origin or any other legally recognized status entitled to protection under applicable laws We are committed to a diverse and inclusive workplace for all If you are contacted for a job opportunity please advise us of any accommodations needed to support you throughout the recruitment and selection process All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience Apply now